Fluid transfer assembly, a fluid transfer system, and a related method

ABSTRACT

Fluid transfer assemblies for transferring fluid into or out of a single vessel and distributing the fluid to multiple other vessels are provided. The fluid transfer assemblies are customizable, substantially aseptic, and single-use. The fluid transfer assemblies may be manufactured by solidifying polymeric materials to form a body around a mandrel with protrusions engaged to fluid conduits and leaving recesses in the solidified polymeric material to stretch the resultant body and remove the mandrel with protrusions. The resultant fluid transfer assembly may be surrounded by a rigid housing and valves may be engaged with the conduits and/or body to control the fluid flow within the fluid transfer assembly.

TECHNICAL FIELD

This disclosure relates generally to a fluid transfer assembly allowingfor the transfer of fluids and, more specifically, to a fluid transferassembly for use in distributing fluids comprising a body and conduitsallowing for the transfer of fluid through the assembly to multiplefluid vessels.

BACKGROUND

During certain manufacturing processes, fluids are created that need tobe distributed from one vessel, to multiple other vessels. Often it isnecessary to transfer fluid out of a single manufacturing vessel tomultiple storage or distribution vessels. In particular, the need totransfer fluid in such a manner often arises in the manufacturing andprocessing of pharmaceuticals, biopharmaceuticals, or otherbiotechnology applications where processes are conducted in vessels ofvarying shapes and sizes. The need for fluid transfer to or from avessel arises in other applications and industries as well, includingbut not limited to, the production of food, cosmetics, paint, chemicals,including hazardous chemicals, and the transfer and handling ofsemiconductor fluids.

Regardless of the industry, in some aspects, during transfers orsampling, the fluid often needs to be transferred to or from a vessel orcontainer where a manufacturing process has occurred, such asfermentation, to or from multiple smaller vessels for storage or furtherdistribution. The vessel where the manufacturing has occurred is oftenlarger than the storage and distribution vessels and thus there is aneed to transfer substantial volumes of fluid into many smaller vesselsfor storage or further distribution. In addition, when making suchtransfers, it may be desirable to distribute the fluid to multiplestorage or distribution containers simultaneously. To accomplish anefficient and substantially aseptic transfer of fluids from a singlevessel to multiple other vessels, it is desirable to control theenvironment through which the fluid flows. For example, the pathway froma manufacturing vessel to a storage or distribution container should besubstantially aseptic along the entire pathway. Furthermore, it may bedesirable that the fluid transfer assembly be safe for use, reliable,and of relatively low-cost construction.

Further, it is desirable to transfer fluid using a fluid transferassembly that is simple to manufacture and adaptable to a variety ofneeds. For example, an end user may need to transfer fluids from amanufacturing vessel to any number of storage, sampling, or distributioncontainers. Accordingly, it may be desirable for a fluid transferassembly to be customizable so that the end user can tailor the assemblyto a particular manufacturing need. Of particular interest is a fluidtransfer assembly that may be manufactured with a variety of materialsto handle a variety of fluid types.

It may also be desirable for a fluid transfer assembly to bemanufactured in as few steps as possible, while still allowing forcustomization.

It may also be desirable to transfer fluid using a single-use fluidtransfer assembly that is pre-sterilized. A pre-sterilized, single-usefluid transfer assembly avoids the need for a bioprocess operator orend-user to assemble and to sterilize the assembly for use.

Thus, a fluid transfer assembly that is relatively simple tomanufacture, customizable with respect to both the materials used aswell as the number of conduits provided and as to fluid control devices,and one that is single-use, substantially aseptic, and relativelyinexpensive is needed.

SUMMARY

Briefly described, there is a method of forming a fluid transferassembly, comprising engaging one or more protrusions extendingoutwardly from a mandrel with one or more fluid conduits; positioningthe mandrel with the one or more protrusions engaging the conduits intoa mold; introducing a polymeric material into the mold to substantiallysurround the mandrel and at least a portion of the conduits engaged withthe one or more protrusions; solidifying the polymeric material in themold to define a fluid transfer assembly comprising a body portionengaged with the conduits; removing the fluid transfer assembly from themold; stretching the body portion into an elongated state; removing themandrel with the one or more protrusions from the fluid transferassembly; and relaxing the fluid transfer assembly into an unelongatedstate from the elongated state such that a fluid channel in fluidcommunication with the one or more conduits is formed within the bodyportion.

In another embodiment, there is disclosed a fluid transfer systemcomprising a mandrel with one or more protrusions extending outwardlytherefrom; one or more fluid conduits configured to engage the one ormore protrusions of the mandrel; a mold configured to receive themandrel and the one or more protrusions therein; polymeric materialconfigured to be introduced into the mold and substantially surround themandrel and at least a portion of the conduits engaged with the one ormore protrusions; and a solidifying mechanism configured to solidify thepolymeric material in the mold to define a body portion engaged with theconduits having an elongation to break of between about 150% and about1,500%.

In another embodiment, there is disclosed a fluid transfer assemblycomprising one or more fluid conduits; an body portion engaged with theconduits and defining a fluid channel within the body portion in fluidcommunication with the one or more conduits when the body portion is inan unelongated state, the body portion having an elongation to break ofbetween about 150% and about 1,500%.

Thus, fluid transfer assemblies, fluid transfer assembly systems, andmethods for production thereof are disclosed that possess distinctattributes and represent distinct improvements. These and other aspects,features, and advantages of the fluid assemblies of this disclosure, andthe methods of manufacture thereof, will be better understood andappreciated upon review of the detailed description set forth below whentaken in conjunction with the accompanying drawing figures, describedbriefly below. According to common practice, the various features of thedrawings may not be drawn to scale. Dimensions and relative sizes ofvarious features and elements in the drawings may be shown enlarged orreduced to illustrate more clearly the embodiments of the invention.

The present disclosure thus includes, without limitation, the followingembodiments.

-   Embodiment 1: A method of forming a fluid transfer assembly    comprising: engaging one or more protrusions extending outwardly    from a mandrel with one or more fluid conduits; positioning the    mandrel with the one or more protrusions engaging the conduits into    a mold; introducing a polymeric material into the mold to    substantially surround the mandrel and at least a portion of the    conduits engaged with the one or more protrusions; solidifying the    polymeric material in the mold to define a fluid transfer assembly    comprising a body portion engaged with the conduits; removing the    fluid transfer assembly from the mold; stretching the body portion    into an elongated state; removing the mandrel with the one or more    protrusions from the fluid transfer assembly; and relaxing the fluid    transfer assembly into an unelongated state from the elongated state    such that a fluid channel in fluid communication with the one or    more conduits is formed within the body portion.-   Embodiment 2: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein removing the mandrel and the one or    more protrusions comprises stretching the body portion via one or    more internal recesses defined by the body portion that enable the    body portion to be stretched from the unelongated state into the    elongated state and subsequently pulling the mandrel to remove the    mandrel with the one or more protrusions from the fluid transfer    assembly.-   Embodiment 3: The method of any preceding or subsequent embodiment,    or combinations thereof, comprising positioning sleeves in the mold    prior to introducing the polymeric material into the mold, the    sleeves defining the one or more internal recesses in the body    portion upon removing the fluid transfer assembly from the mold.-   Embodiment 4: The method of any preceding or subsequent embodiment,    or combinations thereof, further comprising attaching a collar    around an end of at least one of the one or more fluid conduits    prior to the step of introducing the polymeric material.-   Embodiment 5: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the polymeric material of the body    portion is introduced in order to at least partially cover the    collar.-   Embodiment 6: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the polymeric material of the body    portion is introduced in order to substantially entirely cover the    collar.-   Embodiment 7: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the at least one of the one or more    fluid conduits is a thermoplastic conduit, and the polymeric    material is a thermoset, wherein the collar is configured to attach    the thermoplastic conduit into the thermoset body portion.-   Embodiment 8: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the at least one of the one or more    fluid conduits is a thermoplastic conduit, and the polymeric    material is a thermos plastic, wherein the collar is configured to    attach the thermoplastic conduit into the thermoplastic body    portion.-   Embodiment 9: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the at least one of the one or more    fluid conduits is a thermoset conduit, and the polymeric material is    a thermoplastic, wherein the collar is configured to attach the    thermoset conduit into the thermoplastic body portion.-   Embodiment 10: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the at least one of the one or more    fluid conduits is a thermoset conduit, and the polymeric material is    a thermoset, wherein the collar is configured to attach the    thermoset conduit into the thermoset body portion.-   Embodiment 11: The method of any preceding or subsequent embodiment,    or combinations thereof, further comprising providing an adhesive    between the collar and the fluid conduit.-   Embodiment 12: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the fluid conduit is a thermoset    material.-   Embodiment 13: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the fluid conduit is a    thermoplastic material.-   Embodiment 14: The method of any preceding or subsequent embodiment,    or combinations thereof, further comprising applying a primer to an    exterior of the collar.-   Embodiment 15: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein solidifying the polymeric material    comprises curing the polymeric material having an elongation to    break of between about 150% and about 1,500%.-   Embodiment 16: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the one or more protrusions    comprise a length less than or equal to a diameter of the mandrel.-   Embodiment 17: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the polymeric material is a    thermoplastic.-   Embodiment 18: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the polymeric material is a    thermoset.-   Embodiment 19: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the polymeric material is a    silicone elastomer.-   Embodiment 20: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein the polymeric material is a    perfluoropolyether elastomer.-   Embodiment 21: The method of any preceding or subsequent embodiment,    or combinations thereof, comprising securing at least a portion of    the fluid transfer assembly into a rigid housing.-   Embodiment 22: The method of any preceding or subsequent embodiment,    or combinations thereof, wherein a material of the rigid housing is    selected from the group consisting of polyether sulfone, polyester,    polycarbonate, polyamide, polyetherimide, polyether ether ketone,    polyolefins, ethylene tetrafluoro ethylene, aluminum, stainless    steel, carbon fiber epoxy, and glass filled plastics.-   Embodiment 23: The method of any preceding or subsequent embodiment,    or combinations thereof, comprising engaging one or more fluid    control devices with at least one of the conduits and the body    portion, and the housing to control fluid flow within the fluid    transfer assembly.-   Embodiment 24: A fluid transfer system comprising: a mandrel with    one or more protrusions extending outwardly therefrom; one or more    fluid conduits configured to engage the one or more protrusions of    the mandrel; a mold configured to receive the mandrel and the one or    more protrusions therein; polymeric material configured to be    introduced into the mold and substantially surround the mandrel and    at least a portion of the conduits engaged with the one or more    protrusions; and a solidifying mechanism configured to solidify the    polymeric material in the mold to define a body portion engaged with    the conduits having an elongation to break of between about 150% and    about 1,500%.-   Embodiment 25: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the solidified polymeric material    is configured to be stretched into an elongated state while the    mandrel is configured to be subsequently pulled in order to remove    the mandrel with the one or more protrusions from the fluid transfer    assembly.-   Embodiment 26: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the one or more protrusions    comprise a length less than or equal to a diameter of the mandrel.-   Embodiment 27: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the polymeric material is a    thermoplastic.-   Embodiment 28: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the polymeric material is a    thermoset.-   Embodiment 29: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the polymeric material is a    silicone elastomer.-   Embodiment 30: The system of any preceding or subsequent embodiment,    or combinations thereof, comprising a housing configured to receive    at least a portion of the body portion and at least a portion of the    conduits.-   Embodiment 31: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the housing comprises a rigid    material.-   Embodiment 32: The system of any preceding or subsequent embodiment,    or combinations thereof, comprising one or more fluid control    devices configured to be engaged with at least one of the conduits    and the body portion, and the housing to control fluid flow within    the fluid transfer assembly.-   Embodiment 33: The system of any preceding or subsequent embodiment,    or combinations thereof, comprising a sleeve positioned in the mold    to define the one or more internal recesses in the body portion upon    removal of the fluid transfer assembly from the mold.-   Embodiment 34: The system of any preceding or subsequent embodiment,    or combinations thereof, further comprising a collar attached around    an end of at least one of the one or more fluid conduits.-   Embodiment 35: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the polymeric material is    configured to at least partially cover the collar.-   Embodiment 36: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the polymeric material is    configured to substantially entirely cover the collar.-   Embodiment 37: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the at least one of the one or more    fluid conduits is a thermoplastic conduit, and the polymeric    material is a thermoset.-   Embodiment 38: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the at least one of the one or more    fluid conduits is a thermoplastic conduit, and the polymeric    material is a thermoplastic.-   Embodiment 39: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the at least one of the one or more    fluid conduits is a thermoset conduit, and the polymeric material is    a thermoset.-   Embodiment 40: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the at least one of the one or more    fluid conduits is a thermoset conduit, and the polymeric material is    a thermoplastic.-   Embodiment 41: The system of any preceding or subsequent embodiment,    or combinations thereof, further comprising providing an adhesive    between the collar and the fluid conduit.-   Embodiment 42: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the fluid conduit is a thermoset    material.-   Embodiment 43: The system of any preceding or subsequent embodiment,    or combinations thereof, wherein the fluid conduit is a    thermoplastic material.-   Embodiment 44: The system of any preceding or subsequent embodiment,    or combinations thereof, comprising a primer on an exterior of the    collar.-   Embodiment 45: A fluid transfer assembly comprising: one or more    fluid conduits; a body portion engaged with the conduits and    defining a fluid channel within the body portion in fluid    communication with the one or more conduits when the body portion is    in an unelongated state, the body portion having an elongation to    break of between about 150% and about 1,500%.-   Embodiment 46: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the body portion    defines one or more internal recesses that enable the body portion    to be stretched from the unelongated state to an elongated state to    remove a mandrel and one or more protrusions extending outwardly    therefrom from the fluid transfer assembly.-   Embodiment 47: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the one or more    internal recesses are defined by sleeves positioned in the mold to    define the one or more internal recesses in the body portion upon    removal of the fluid transfer assembly from the mold.-   Embodiment 48: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the body portion or the    one or more fluid conduits comprises a polymeric material.-   Embodiment 49: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the polymeric material    comprises at least one of a thermoplastic conduit, a thermoset    conduit, and a silicone elastomer body portion.-   Embodiment 50: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the one or more    protrusions comprises a length less than or equal to a diameter of    the mandrel.-   Embodiment 51: The assembly of any preceding or subsequent    embodiment, or combinations thereof, comprising a housing configured    to receive at least a portion of the body portion and at least a    portion of the one or more conduits.-   Embodiment 52: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the housing comprises a    rigid material.-   Embodiment 53: The assembly of any preceding or subsequent    embodiment, or combinations thereof, comprising one or more fluid    control devices configured to be engaged with at least one of the    one or more conduits and the body portion, and the housing to    control fluid flow within the fluid transfer assembly.-   Embodiment 54: The assembly of any preceding or subsequent    embodiment, or combinations thereof, further comprising a collar    attached around an end of at least one of the one or more fluid    conduits adjacent to the fluid channel.-   Embodiment 55: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the polymeric material    is configured to at least partially cover the collar.-   Embodiment 56: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the polymeric material    is configured to substantially entirely cover the collar.-   Embodiment 57: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the at least one of the    one or more fluid conduits is a thermoplastic conduit, and the    polymeric material is a thermoset.-   Embodiment 58: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the at least one of the    one or more fluid conduits is a thermoplastic conduit, and the    polymeric material is a thermoplastic.-   Embodiment 59: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the at least one of the    one or more fluid conduits is a thermoset conduit, and the polymeric    material is a thermoset.-   Embodiment 60: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the at least one of the    one or more fluid conduits is a thermoset conduit, and the polymeric    material is a thermoplastic.-   Embodiment 61: The assembly of any preceding or subsequent    embodiment, or combinations thereof, further comprising providing an    adhesive between the collar and the fluid conduit.-   Embodiment 62: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the fluid conduit is a    thermoset material.-   Embodiment 63: The assembly of any preceding or subsequent    embodiment, or combinations thereof, wherein the fluid conduit is a    thermoplastic material.-   Embodiment 64: The assembly of any preceding or subsequent    embodiment, or combinations thereof, comprising a primer on an    exterior of the collar.

These and other features, aspects, and advantages of the presentdisclosure will be apparent from a reading of the following detaileddescription together with the accompanying drawings, which are brieflydescribed below. The present disclosure includes any combination of two,three, four, or more features or elements set forth in this disclosureor recited in any one or more of the claims, regardless of whether suchfeatures or elements are expressly combined or otherwise recited in aspecific embodiment description or claim herein. This disclosure isintended to be read holistically such that any separable features orelements of the disclosure, in any of its aspects and embodiments,should be viewed as intended, to be combinable, unless the context ofthe disclosure clearly dictates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded perspective view of a fluid transfer assembly withmultiple fluid transfer conduits, a housing, and fluid control devices.

FIG. 2 is a perspective view of a fluid transfer assembly, with multiplefluid transfer conduits, a housing, and fluid control devices.

FIG. 3 is an exploded perspective view of a fluid transfer assembly withmultiple fluid transfer conduits, a housing, and fluid control devices.

FIG. 4 is a cross-section of a fluid transfer assembly with multiplefluid conduits, a housing, and fluid control devices.

FIG. 5 is a cross-section of a fluid transfer assembly with multiplefluid transfer conduits, a housing, and fluid control devices.

FIG. 6 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits.

FIG. 7 is a cross-section of a fluid transfer assembly with multiplefluid transfer conduits.

FIG. 8 is a cross-section of a fluid transfer assembly with multiplefluid transfer conduits.

FIG. 9 is a cross-section of a body of the fluid transfer assembly ofFIG. 8.

FIG. 10 is an exploded perspective view of a fluid transfer assemblyshowing two fluid transfer conduits and a housing.

FIG. 11 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits inside a bottom portion of a housing.

FIG. 12 is a top view of a fluid transfer assembly with multiple fluidtransfer conduits on a stretching fixture in an unelongated state.

FIG. 13 is a top view of a fluid transfer assembly with multiple fluidtransfer conduits on a stretching fixture in an elongated.

FIG. 14 is a perspective view of a mold.

FIG. 15 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits within a mold.

FIG. 16 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits within a mold having a raised surface.

FIG. 17 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits.

FIG. 18 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits within a housing and with fluid control devices.

FIG. 19 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits within a housing, the multiple fluid transferconduits extending radially from the assembly.

FIG. 20 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits, a housing, and fluid control devices.

FIG. 21 is an exploded perspective view of a fluid control device.

FIG. 22 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits, a housing, and sensors.

FIG. 23 is a fluid transfer assembly with two separate fluid pathwayswithin the body and multiple fluid transfer conduits extending from eachfluid pathway within the body.

FIG. 24 is a perspective view of a fluid transfer assembly with a singlefluid transfer conduit, a housing, and a fluid control device.

FIG. 25 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits, a housing, and fluid control devices.

FIG. 26 is a perspective view of a fluid transfer assembly with a singlefluid transfer conduit and a housing.

FIG. 27 is a perspective view of a fluid transfer assembly with a singlefluid transfer conduit.

FIG. 28 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits.

FIG. 29 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits.

FIG. 30 is a perspective view of a fluid transfer assembly with multiplefluid transfer conduits.

FIG. 31 is a perspective view of a fluid transfer assembly with a singlefluid transfer conduit.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Certain exemplary embodiments of the present invention are describedbelow and illustrated in the accompanying figures. The embodimentsdescribed are only for purposes of illustrating the present inventionand should not be interpreted as limiting the scope of the invention,which, of course, is limited only by the claims below. Other embodimentsof the invention, and certain modifications and improvements of thedescribed embodiments, will occur to those skilled in the art, and allsuch alternate embodiments, modifications, and improvements are withinthe scope of the present invention.

In some aspects, a fluid transfer assembly, a fluid transfer system,and/or a related method are used for distribution of fluid between largeand small vessels. For example, such a fluid transfer assembly and/orsystem may be useful for sampling a small volume off of a line or bodywhen transferring from one vessel to another vessel, whether or notthose vessels are of the same size. In another example, such a fluidtransfer assembly and/or system may be useful for adding one or morefluids from one vessel into another vessel (e.g., a small size vesselinto a larger size vessel). In a further example, such a fluid transferassembly and/or system may be useful for incorporating into vesselclosures (e.g., MYCAP™) for the addition or removal of one, two, three,four, etc., fluids within the same vessel.

Referring now in more detail to the drawing figures, wherein likereference numerals indicate like parts throughout the several views,FIG. 1 depicts an exploded perspective view of a fluid transferassembly, generally designated as 100. In particular, a “fluid transferassembly” 100 as used throughout this disclosure comprises one or morefluid conduits 110 and a lengthened body portion 120 engaged with theconduits 110. In some aspects, for example, the fluid transfer assembly100 is not limited to the number of fluid conduits shown in FIG. 1, butmay incorporate more or fewer conduits as shown throughout the figures.The fluid transfer assembly 100 is thus suitable for use with vesselsthat include without limitation: containers, beakers, bottles,canisters, flasks, bags, receptacles, tanks, vats, vials, tubes, and thelike that are generally used to contain fluids, slurries, cells, drugproducts, and other similar substances.

It should be understood that the fluid transfer assembly 100 is also notlimited to use with any particular fluids but, depending on the size andcomposition of the assembly 100 and its constituent fluid conduits 110,may be used with fluids with particulates or having a high viscosity orwith fluids having no or very little particulate content or lowviscosity.

In some aspects, the body portion 120 is longer in a longitudinaldimension (length) rather than a lateral dimension (width) so that thebody portion 120 is substantially rectangular shaped. In other aspects,however, the body portion 120 is substantially square, triangular,circular, etc., relative to a length and width dimension. Accordingly,although not shown in FIG. 1, a fluid channel may be defined within thebody portion 120. The fluid channel may be in fluid communication withthe one or more conduits 110.

The fluid conduits 110 are in some aspects considered as being “long”relative to a length of the body portion 120. For example, the fluidconduits 110 comprise a length of between about 1 inch and about 100inches or longer depending on the application. The fluid conduits 110may be selectable depending on whether or not a longer or shorterconduit is desirable for a particular application. Example fluidconduits 110 may have a 1/16″ wall thickness.

In some aspects, a material of the body portion 120 comprises a materialhaving an elongation to break of between about 150% and about 1,500% perASTM D412C. In some aspects, the material of the body portion 120 is arubber or other type of elastomer such as a solidified polymericmaterial. For example, the polymeric material comprises a thermoplastic,a thermoset, a silicone elastomer, a combination thereof, and the like.Other materials having an elongation to break of between about 150% andabout 1,500% are also contemplated.

In other aspects, a material of the conduits 110 is a same or similarmaterial to that of the body portion 120. More particularly, the fluidconduits are silicone tubing. The tubing may be of any length suitableand necessary for the desired process. In one embodiment, at least aportion of the silicone tubing is treated with a primer. Suitableprimers include, but are in no way limited to, SS-4155 available fromMOMENTIVE™, Med-162 available from NuSil Technology, and RODORSIL® V-O6Cavailable from Bluestar Silicones of Lyon, France. Further, in thispreferred embodiment, the silicone conduits are combined with a siliconebody portion.

In general, if a thermoset is used for the body, silicones,polyurethanes, fluoroelastomers or perfluoropolyethers are preferredconstruction materials for the conduits. If a thermoplastic is used forthe body, C-FLEX® tubing, block copolymers ofstyrene-ethylene-butylene-styrene, PureWeld, PVC, polysulfone,polyetheretherketone, polyolefins, or polyethylene are preferredconstruction materials. In some aspects, multiple conduits may be usedincluding combinations of thermoset and thermoplastic materials for theconduits in the same fluid transfer assembly (e.g., a thermoplasticconduit and a thermoset conduit is provided in a fluid transferassembly). As such, in some examples, the conduits 110 comprise athermoplastic or a thermoset material and the body portion 120 comprisesa silicone elastomer material.

In some aspects, the fluid conduits 110 extending from the fluidtransfer assembly 100 may be connected to a variety of vessels forcollection. Acceptable vessels include, without limitation, bags,bottles, syringes, centrifuge tubes, or tubing. A plug may also beinserted in the end of the fluid conduits 110. An aseptic connector mayalso be inserted into the end of the fluid conduit. The fluid conduits110 may also be connected to additional fluid control devices. The fluidtransfer assembly 100 may further comprise a housing 130. In someaspects, the fluid transfer assembly 100 is partially engaged with ahousing 130. The housing 130 comprises a bottom portion 132 engaged withthe fluid transfer assembly 100, while a top portion of the housing 134is disengaged therewith. As used herein, the housing 130 is considered“rigid” relative to the fluid transfer assembly 100. The rigidity of thehousing refers to material properties of the housing 130, such that thehousing, itself, is more inflexible and unable to be bent or stretchedrelative to the conduits 110 and/or the body portion 120 of the fluidtransfer assembly 100. A material of the housing 130, e.g., of thebottom portion 132 and/or the top portion 134, may be selected from thegroup consisting of polyether sulfone, polyester, polycarbonate,polyamide, polyetherimide, polyether ether ketone, polyolefins, ethylenetetrafluoro ethylene, aluminum, stainless steel, carbon fiber epoxy, andglass filled plastics. Other materials are also contemplated.

In FIG. 1, the bottom portion 132 of the housing is able to engage orsecure at least a portion of the fluid transfer assembly 100 thereinsuch that a substantial portion of the body portion 120 and at least aportion of the conduits 110 are secured within the bottom portion 132.The top portion 134, as shown in FIG. 1 is able to be aligned with thebottom portion 132 to securely enclose a substantial portion of the bodyportion 120 and at least a portion of the conduits 110 therein. In someaspects, bores provided along the bottom and top portions 132, 134 ofthe housing are able to receive fasteners such as screws, bolts, and thelike to fixedly retain the two portions together. Other more permanentmechanisms for retaining the two in alignment such as a permanentsolvent or adhesive or ultrasonic welding are also contemplated.

In some aspects, one or more fluid control devices such as valves 140are engaged with at least one of the conduits 110 and the body portion120 and the housing 130. Notably, as is known to those of ordinaryskill, valves are considered as more reliable than some other types offlow control devices such as, for example, pinch clamps. In this manner,the fluid control devices provided herein provided ultimate usercontrollability and security.

As illustrated in FIG. 1, for example, five fluid control devices, inthis embodiment, pinch valves 140, are provided, which are secured withthe body portion 120 by way of the top portion 134 of the housing.However, less or more valves of different styles, sizes, types, etc.,are contemplated. In this way, fluid flow within the fluid transferassembly is controlled, obstructed, enabled, and the like. In someaspects, the valves 140 comprise handles for ease of use or manipulationfor a user. Valve stops provided within the top portion 134 of thehousing act to limit rotation of the handle. A more detailed view of anexemplary valve is described in reference to FIG. 21.

In some aspects, the fluid transfer assembly 100 comprises additionalelements. For example, the body portion 120 comprises a proximal orfirst end and an opposing or distal end. The proximal end defines tubing150 such as, for example, a thermoplastic tubing in fluid communicationwith the fluid channel defined within the body portion. Thethermoplastic tubing 150 is configured to be weldable to otherthermoplastic tubing in an aseptic manner.

In other aspects, the distal end defines a tube stub 160 to engage abarb to another fluid transfer assembly, or a single-use component(e.g., a filter) to form a closed system. In such aspects, the clampinterface 160 is a threaded connection, a clamp connection, a weldedconnection, a bonded connection, or any other mechanical connection.Alternatively, the clamp interface 160 is formed as a singular unit withthe vessel, other fluid transfer assembly, the single-user component,etc. For example, a bioreactor bag may be formed in a manner whereby thefluid transfer assembly (e.g., the body portion) is formed as anintegral component of the bag when the bag is manufactured. Regardlessof whether the fluid transfer assembly is a separate component, orformed as an integral part of the vessel, the fluid transfer assembly100 is combined with the vessel to form a substantially asepticleak-free connection. As such, the housing 130 is configured to encloseat least a portion of the tubing 150 as well as at least a portion ofthe clamp interface 160 therein, as well as any other portion of thefluid transfer assembly 100.

FIGS. 2-5 illustrate a fluid transfer assembly 200, similar to thatillustrated in FIG. 1. The fluid transfer assembly 200 comprises tenconduits 210 and a body portion 220. In FIG. 2, a housing 230 having abottom portion 232 and a top portion 234 are engaged to receive at leasta portion of the fluid transfer assembly 200 (i.e., at least a portionof the body portion 220 and at least a portion of the conduits 210)therein. Ten valves 240 each engaged with an individual conduit 210 andthe top portion 234 of the housing are provided in FIGS. 2-5. Thus, thevalves 240 are configured to control the fluid flow within the fluidtransfer assembly 200.

Similar to FIG. 1, the body portion 220 illustrated in FIGS. 2-5comprises a proximal end defining tubing 250 such as, for example, athermoplastic tubing in fluid communication with the fluid channeldefined within the body portion 220. In other aspects, an opposingdistal end defines a clamp interface 260 that functions similar to thetube stub 160 in FIG. 1. In some aspects, the proximal end definingtubing 250 may be surrounded by a collar 264 as shown in FIG. 4. Thecollar 264 may be a cylindrical tube with a wall thickness of about0.032″. The collar 264 may be useful for retaining a distal end of thetubing 250 in connection with the body portion 220. In one aspect, thebody portion 220 is configured to cover at least a portion of the collar264. In another aspect, the body portion 220 may be configured tosubstantially cover an exterior end of the collar 264. In anotheraspect, the body portion 220 may be configured to substantially fullycover the collar 264 such that the collar is substantially fullyembedded within the body portion. In these aspects, the collar 264 maybe metallic or polymeric and attached to the tubing 250 with anadhesive. The adhesive may be applied with a thickness on the order ofabout 0.005″. The use of a collar 264 to help prevent separation fromthe body portion 220 may also be applied to one or more of the fluidconduits 210.

In some aspects, the collar 264 may be beneficial to facilitate tyingtogether dissimilar materials. When used to assist the coupling ofdissimilar materials, the collar 264 may preferably comprise a metalmaterial. For example, where the body portion 220 is formed from asilicone elastomer or similar thermoset material, and one of the tubing250 or one of the fluid conduits 210 is made from a thermoplasticmaterial, the collar 264 may strengthen the joint therebetween.Particularly, the collar 264 can be positioned around the end of thetubing 250 (or fluid conduit 210) that is overmolded with the bodyportion 220. In one aspect, an adhesive may be used to join the collar264 to the fluid conduit 210 or tubing 250. In one aspect, a primer maybe applied to an exterior of the collar 264 to promote bonding with thebody portion 220 that is formed from silicone elastomer or otherthermoset material with sufficient elongation to break. One skilled inthe art will appreciate that a silicone elastomer may be considered aspecific example of a thermoset material.

In yet another embodiment, the collar 264 may be a thermoplasticmaterial and can be attached to the distal end of the tubing 250 orfluid conduits 210 using an adhesive, such as a hot melt adhesive. In afurther embodiment, the body portion 220 may be formed from athermoplastic elastomer having an elongation to break of between about150% and about 1500%.

To conclude, collars 264 may be used on one or more of the tubing 150,250, etc. and fluid conduits 110, 210, etc. In various embodiments thecollars 264 may be metallic, thermoplastic, thermoset, silicone, orother material. The collars 264 may be used between similar materialssuch as a thermoplastic body portion and thermoplastic fluid conduits,or a thermoset body portion and a thermoset fluid conduit, or a siliconeelastomer body portion and a silicone elastomer fluid conduit. Collars264 may be particularly beneficial when used between dissimilarmaterials, such as a silicone elastomer (or thermoset) body portion andthermoplastic fluid conduits, or a thermoplastic body portion andthermoset or silicone elastomer fluid conduit.

Referring now to FIGS. 6-8, a view of the fluid transfer assembly 200 isillustrated in greater detail. In some aspects, the body portion 220defines one or more internal recesses 270 that enable the body portion220 to be stretched from the unelongated state to an elongated state.Stresses are applied to the body portion 220 other than typical stressesto stretch the body portion 220 to the elongated state. For example, andas illustrated in FIGS. 12 and 13, a stretching fixture 300 (e.g., avice) comprising a plurality of pins 302 that align with each of theinternal recesses 270 of the body portion 220 is usable to engage theinternal recesses 270 of the body portion 220 and thus stretch the bodyportion 220 in a direction relative to the longitudinal axis of the bodyportion 220. FIG. 12 illustrates the fluid transfer assembly 200 in anunelongated state having the internal recesses 270 aligned with the pins302, while FIG. 13 illustrates the fluid transfer assembly 200 in anelongated or “stretched” state. In this manner, a mandrel 304 and one ormore protrusions 306 extending outwardly from the mandrel may be removedfrom the fluid transfer assembly, which will be described in furtherdetail below.

Notably, with regard to the stretching fixture 300, this is only oneexemplary embodiment of a stretching fixture, apparatus, or mechanismthat is able to engage the internal recesses 270 of the body portion 220of a fluid transfer assembly 200 or other similar assembly. Other suchembodiments of a stretching fixture are also contemplated, including,for example, a hook used for radial expansion to remove the mandrel(see, e.g., FIG. 19).

Referring now to FIG. 9, a cross-section of the fluid channel definedwithin the body portion 220 of the fluid transfer assembly 200 isillustrated. As described below, a fluid channel of a fluid transferassembly is formed in the following manner.

A method of forming a fluid transfer assembly is provided herein. Themethod of forming the fluid transfer assembly or system provided hereinprovides numerous benefits or advantages such as simplifyingmanufacturing costs and time by utilizing fluid conduits formed fromtubing rather than from molding “Y joints” to a manifold. The method offorming the fluid transfer assembly or system provided herein providesfurther benefits or advantages by reducing a number of connectionsneeded to be made between vessels from which fluid is transferred. Forexample, the fluid conduits of the fluid transfer assembly and the fluidchannel defined within the body portion thereof provide a simple flowpath for fluid flow from a first vessel to a second vessel. Additionalvessels may be easily connected to additional fluid conduits (not inuse) of the fluid transfer assembly for fluid flow from the first vesselto the second vessel and the additional vessels. The method providedherein is also advantageous in that there is added security in that thefluid transfer assembly more securely engages with vessels as comparedto barb fittings that leak under pressure or luers that may come undoneduring use.

In an initial step, one or more protrusions 306 extending outwardly froma mandrel 304 may be engaged with one or more fluid conduits 210 such asshown in FIG. 12. As used herein, a mandrel may comprise one known tothose of ordinary skill in the art. The one or more protrusions mayradially extend off the mandrel at varying intervals depending on anumber of conduits desired. For example, if there are five pairs ofconduits to be used in the fluid transfer assembly, the mandrel maycomprise five pairs of equally spaced apart protrusions about a lengthof the mandrel. In some aspects, a size and/or shape of the mandreland/or the protrusions depends on the fluid transfer assembly'sapplication. For example, where it is desirable to have a fluid transferassembly having a body portion of a specific length and conduits of aspecific diameter, a length and/or diameter of the mandrel and adiameter of the protrusions may be sized accordingly. In some aspects, across-sectional area of the flow channel defined by the body portion isdependent upon a diameter of the mandrel. In a preferred aspect, the oneor more protrusions comprise a length less than or equal to a diameterof the mandrel.

In another step, the mandrel with the one or more protrusions engagingthe conduits may be positioned into a mold. FIGS. 14 and 15 illustratean exemplary mold 400. The mold 400 comprises a two part mold having abottom portion 410 and a top portion 420. In some aspects, the bottomportion 410 defines a cavity 412 for receiving the mandrel with the oneor more protrusions engaged with the conduits therein. Relief sections414 defined along a periphery of the longitudinal edges of the bottomportion 410 are provided for receiving the fluid conduits therein. Insome aspects, the top portion 420 comprises one or more posts 422 toform the internal recesses within the body portion. The posts 422 are,in some aspects, a metallic or other rigid material. Like the bottomportion 410, the top portion 420 may comprise relief sections 424defined along a periphery of the longitudinal edges for receiving thefluid conduits therein. Sleeves may be inserted over the posts beforemolding occurs such that the sleeves are incorporated into and madeintegral with the recess within the body portion after molding. In thismanner, the sleeves are configured to strengthen and prevent damage tothe body portion of the fluid transfer assembly during elongation, asdescribed herein. As such, the sleeves may be a material selected fromthe group consisting of polyether sulfone, polyester, polycarbonate,polyamide, polyetherimide, polyether ether ketone, polyolefins, ethylenetetrafluoro ethylene, aluminum, stainless steel, carbon fiber epoxy, andglass filled plastics or any other similar material. After the mandrelis positioned in the bottom portion 410, the top portion 420 of the moldis then able to be aligned with the bottom portion 410 and secured viaany type of securing mechanism (e.g., clamps, fasteners, etc.) As such,in a closed and secured position, the mold 400 may resemble the mold inFIG. 15, where fasteners 430 extend through the top portion 420 and intothe bottom portion 410 of the mold 400. Alternatively, as illustrated inFIG. 16, a mold 500 having a bottom portion 510 and a top portion 520comprises a raised surface 522 on at least a top portion 520, which isconfigured to allow fasteners to not extend past a surface thereof whenthe mold 500 is in a closed and secured position. In some aspects, theraised surface 522 is machined.

In another step, a polymeric material may then be introduced into themold 400 to substantially surround the mandrel and at least a portion ofthe conduits engaged with the one or more protrusions. The polymericmaterial introduced therein may comprise a polymeric material asdescribed herein. Depending on a size of the cavity 412, a predeterminedquantity of polymeric material may be introduced into the mold 400.

In another step, the polymeric material in the mold may be solidified todefine a fluid transfer assembly (e.g., fluid transfer assembly 100,200) comprising a body portion engaged with the one or more conduits.For example, solidification of the polymeric material comprises curingthe polymeric material having an elongation to break of between about150% and about 1,500%. “Curing” refers to toughening or hardening thematerial by cross-linking the polymer chains by heat, chemicaladditives, ultraviolet radiation, electron beams, pressure, and thelike. A high or lower powered laser, an oven, or other curing mechanismmay be utilized to cure the polymeric material until cross-linking ofthe polymer chains occurs. Otherwise, solidification refers to theheating and subsequently cooling of the polymeric material as athermoplastic about the mandrel to thereby join the one or more conduitstogether within the mold. Regardless, the molding step results injoining one or more conduits together using the polymeric material andthe mandrel. In another step, the fluid transfer assembly may be removedfrom the mold 400. For example, removing the fluid transfer assemblyfrom the mold comprises opening the mold 400 by unfastening the top andbottom portions 410, 420 and removing the solidified polymeric materialtherefrom. The mandrel and the one or more protrusions extendingoutwardly from the mandrel with the one or more conduits engagedtherewith will have formed a solidified body portion that is readilyremovable from the mold in substantially one piece.

In another step, the body portion may be stretched into an elongatedstate to remove the mandrel with the one or more protrusions. Forexample, as described hereinabove in reference to FIG. 13, one or moreinternal recesses defined by the body portion enable the body portion tobe stretched from the unelongated state into the elongated state. Inanother step, the mandrel with the one or more protrusions may beremoved from the fluid transfer assembly. More particularly, while thefluid transfer assembly remains in the elongated state on the stretchingfixture or vice (e.g., 300) the mandrel and the one or more protrusionsmay be pulled from the fluid transfer assembly in a longitudinaldirection.

In another step, the fluid transfer assembly may then be relaxed into anunelongated state from the elongated state such that a fluid channel influid communication with the one or more conduits is formed within thebody portion. More particularly, and as illustrated in FIGS. 10 and 11,removal of the mandrel and the one or more protrusions results in thefluid channel remaining within the body portion 220 of the fluidtransfer assembly 200. Thus, fluid flow between the conduits, the fluidchannel, the tubing 150, and any vessel engaged with a clamp interfaceis provided. As such, a fluid transfer assembly having a fluid channelwith a diameter larger than a diameter of conventionally produced fluidtransfer assembly results due to the removal of the mandrel from aninterior of thereof.

In some aspects, a fluid transfer system is provided. For example, thefluid transfer system comprises the elements for manufacturing a fluidtransfer assembly such as fluid transfer assembly 100 and/or 200. Theelements of the fluid transfer system include, for example, a mandrelwith one or more protrusions extending outwardly therefrom, one or morefluid conduits configured to engage the one or more protrusions of themandrel, a mold configured to receive the mandrel and the one or moreprotrusions therein, a polymeric material configured to be introducedinto the mold and substantially surround the mandrel and at least aportion of the conduits engaged with the one or more protrusions, and asolidifying mechanism configured to solidify the polymeric material inthe mold to define a body portion engaged with the conduits having anelongation to break of between about 150% and about 1,500%.

In some aspects, a housing configured to receive at least a portion ofthe body portion and at least a portion of the conduits, one or morefluid control devices, such as pinch valves, configured to be engagedwith at least one of the conduits and the body portion, and the housingto control fluid flow within the fluid transfer assembly, and/or asleeve positioned in the mold to define the one or more internalrecesses in the body portion upon removal of the fluid transfer assemblyfrom the mold are also provided with the system. Other elements are alsocontemplated.

FIG. 17 illustrates an exemplary fluid transfer assembly 600 having fourfluid conduits 610, a body portion 620, a housing 630, two opposingclamps 640, and six internal recesses 650. FIG. 18 illustrates anexemplary fluid transfer assembly 700 having four fluid conduits 710, asquare-shaped body portion 720, a housing 730, four valves 740, and twoopposing clamps 750.

FIG. 19 illustrates an exemplary fluid transfer assembly 800 havingforty fluid conduits 810, a body portion 820 from which the conduits 810radially extend, a tubing 830 at a proximal end of the body portion 820and a clamp interface 840 and an opposing distal end of the body portion820. The forty fluid conduits 810 are arranged in equally spaced sets often conduits per side of a rectangular shaped body portion 820. Betweena spacing of each conduit 810 at a point of engagement on the bodyportion 820, an internal recess 850 is defined therein. The internalrecesses 850 are sized for a hook or other stretching fixture (e.g.,fixture 400) to engage the internal recesses 850 and radially stretchthe body portion 820 from an unelongated state into an elongated stateand subsequently pull a mandrel internally therefrom to remove themandrel with one or more protrusions from the fluid transfer assembly800. The hook (not shown) is thus a different stretching fixture thanthat illustrated in FIGS. 12 and 13. A fluid transfer assembly withmultiple (e.g., hundreds) of conduits may be manufactured with such amethod.

FIG. 20 illustrates an exemplary fluid transfer assembly 900 having tenfluid conduits 910, a rectangular shaped body portion 920, a housing930, five valves 940, a tubing 950, and a clamp interface 960. The tenfluid conduits 910 are disposed only on a single side of the bodyportion 920.

FIG. 21 illustrates a detailed view of a fluid control device or valve1000 as described above in reference to FIG. 1. The valve 1000 comprisesa handle 1002 is shaped as an “anvil” that is rotatable within aninclined bore 1004 provided within a housing. In some aspects, forexample, the inclined bore 1004 comprises a wedge shaped protrusionprovided at a bottom thereof. In this manner, rotation of the handle1002 clockwise or counterclockwise applies pressure to the conduit(e.g., 110) with which the valve 1000 is engaged in order to obstruct orremove such obstruction from the fluid flow of the fluid channel. Insome aspects, the valve 1000 is a pinch valve. In other aspects, thefluid control device may be provided within a body of the fluid transferassembly using, for example, a hemispherically tipped pinch element.

FIG. 22 illustrates an exemplary fluid transfer assembly 1100 havingthree fluid conduits 1110, a rectangular shaped body portion 1120, ahousing 1130, a tubing 1140, a clamp interface 1150, and two sensingmechanisms or sensors 1160. The three fluid conduits 1110 are disposedin an uneven disposition, with two fluid conduits 1110 being disposed onone side of the rectangular shaped body portion 1120 and the third fluidconduit 1110 being positioned on an opposing side of the body portion1120. One of the two sensors 1160 is disposed adjacent the third fluidconduit 1110, while the remaining sensor 1160 extends from a top surfaceof the housing 1130. The sensors 1160 are configurable to measure ordetermine temperature, pH, pressure, cell density, perform opticalinspection, etc., of the fluid flow within the fluid channel definedwithin the fluid transfer assembly. In some alternative aspects, notshown, the sensors 1160 are configured as optical fibers for remotesensing.

FIG. 23 illustrates an exemplary fluid transfer assembly 1200 having twoindependent fluid channels or pathways defined therein. Each of thefluid channels is in fluid communication with ten fluid conduits 1210,such that the fluid transfer assembly comprises 20 fluid conduits intotal. The fluid transfer assembly comprises a rectangular body portion1220, a tubing 1230, two tube stubs 1240, and a plurality of internalrecesses 1250. The 20 fluid conduits 1210 are disposed in ten sets oftwo conduits each on opposing sides of the rectangular shaped body 1220.Notably, the two tube stubs 1240 provide independent and separateoutlets for the separate fluid transfer assemblies provided within thefluid transfer assembly 1200. Otherwise, the structure designated 1240could also be representative of a clamp interface.

FIG. 24 illustrates an exemplary fluid transfer assembly 1300 having onefluid conduit 1310, a square-shaped body portion 1320, a housing 1330, avalve 1340, and two clamps 1350. FIG. 25 illustrates an exemplary fluidtransfer assembly 1400 having two fluid conduits 1410, a rectangularshaped body portion 1420, a housing 1430, two valves 1440, and twoclamps 1450. The two fluid conduits 1410 are provided on a same side ofthe body portion 1420.

FIG. 26 illustrates an exemplary fluid transfer assembly 1500 having onefluid conduit 1510, a square-shaped body portion 1520, a housing 1530,and two clamps 1540. FIG. 27 illustrates an exemplary fluid transferassembly 1600 having one fluid conduit 1610, a square-shaped bodyportion 1620, two clamps 1630, and four internal recesses 1640. FIG. 28illustrates an exemplary fluid transfer assembly 1700 having two fluidconduits 1710, a rectangular shaped body portion 1720, two clamps 1730,and six internal recesses 1740. The two fluid conduits 1710 are disposedon a same side of the body portion 1720.

FIG. 29 illustrates an exemplary fluid transfer assembly 1800 having twofluid conduits 1810, a rectangular shaped body portion 1820, a tubing1830, a clamp interface 1840, and six internal recesses 1850. The twofluid conduits 1810 are disposed on a same side of the body portion1820.

FIG. 30 illustrates an exemplary fluid transfer assembly 1900 having twofluid conduits 1910, a rectangular shaped body 1920, a tubing 1930, aclamp interface 1940, and four internal recesses 1950. The two fluidconduits 1910 are disposed on a same side of the body portion 1920. FIG.31 illustrates an exemplary fluid transfer assembly 2000 having onefluid conduit 2010, a rectangular shaped body 2020, a tubing 2030, atube stub 2040, and two internal recesses 2050.

As such, the fluid transfer assemblies described herein may comprise anynumber of conduits, any size or shape body portions, any number ofvalves, any number or type of tubings, any number or type of fluidcontrol devices, any number of clamps, and/or any number of internalrecesses. A disposition and/or placement of any of these elements of thefluid transfer assembly are contemplated by this disclosure and shown bythe numerous exemplary embodiments provided herein.

The fluid transfer assembly, system, and related method disclosed hereinare low cost and single-use but still capable of effectuating asubstantially aseptic seal to a vessel while still allowing maximumflexibility. In addition, the related method provides a method forforming a fluid transfer assembly of relatively few components all whilemaintaining a substantially aseptic assembly in which the fluid mayflow.

The fluid transfer assemblies disclosed herein may be assembled and thenthe entire devices or components thereof may be rendered substantiallyaseptic by, for example, gamma radiation. Alternatively, the entiredevices or components thereof may be rendered substantially aseptic byexposure to steam above 121° C. for a period of time long enough toeliminate microorganisms. The entire devices or components thereof mayalso be rendered aseptic by chemical treatment, such as with ethyleneoxide (ETO). Once rendered substantially aseptic, the fluid transferassemblies may be appropriately packaged and stored to maintain thesubstantially aseptic state until ready for use.

The aforementioned fluid transfer assemblies are particularly usefulwhen the vessel from which fluid is being transferred is a bioreactorbag. Such fluid transfer assemblies, combined with a bioreactor bag, maybe used in single-use bioreactors, such as the BIOSTAT® STR availablefrom Sartorius. Fluid conduits may be sized to accommodate high densitycell culture applications and provide a sterile, low-cost manner ofcollecting samples from bioreactor bags without the risk of leakage. Asdiscussed above, the fluid transfer assemblies provided herein may beconnected to a variety of sample vessels or additional fluid transferassemblies.

The fluid transfer assemblies and/or systems as well as a primary vessel(such as the bioreactor bag), may be rendered substantially aseptic bythe methods described above or others known in the art. Once renderedaseptic, the entire fluid transfer assembly or system may be asepticallypackaged and distributed for use. An end user may open and utilize acompletely closed and substantially aseptic system without risk of leaksdue to the barbed or luer connectors extending from a bioreactor vessel.The foregoing descriptions of fluid transfer assemblies, fluid transfersystems, and related methods illustrate and describe variousembodiments. As various changes can be made in the above embodimentswithout departing from the scope of the invention disclosed and claimedherein, it is intended that all matter contained in the abovedescription or shown in the accompanying figures shall be interpreted asillustrative and not limiting. Furthermore, the scope of the inventioncovers various modifications, combinations, alterations, etc., of theabove-described embodiments that all are within the scope of the claims.Additionally, the disclosure shows and describes only selectedembodiments of the invention, but the invention is capable of use invarious other combinations, modifications, and environments and iscapable of changes or modifications within the scope of the inventiveconcept as expressed herein, commensurate with the above teachings,and/or within the skill or knowledge of artisans in the relevant art.Furthermore, certain features and characteristics of each embodiment maybe selectively interchanged and applied to other illustrated andnon-illustrated embodiments of the invention without departing from thescope of the invention.

The invention claimed is:
 1. A method of forming a fluid transferassembly comprising: engaging one or more protrusions extendingoutwardly from a mandrel with one or more fluid conduits, the one ormore protrusions extending from the mandrel in a direction away from alongitudinal axis of the mandrel; positioning the mandrel with the oneor more protrusions engaging the conduits into a mold; introducing apolymeric material into the mold to substantially surround the mandreland at least a portion of the conduits engaged with the one or moreprotrusions; solidifying the polymeric material in the mold to define afluid transfer assembly comprising a body portion engaged with theconduits; removing the fluid transfer assembly from the mold; stretchingthe body portion into an elongated state; removing the mandrel with theone or more protrusions extending therefrom from the fluid transferassembly; and relaxing the body portion into an unelongated state fromthe elongated state such that a fluid channel in fluid communicationwith the one or more conduits is formed within the body portion.
 2. Themethod of claim 1, further comprising attaching a collar around an endof at least one of the one or more fluid conduits prior to the step ofintroducing the polymeric material.
 3. The method of claim 2, whereinthe polymeric material of the body portion is introduced in order to atleast partially cover the collar.
 4. The method of claim 3, wherein thepolymeric material of the body portion is introduced in order tosubstantially entirely cover the collar.
 5. The method of claim 2,wherein the at least one of the one or more fluid conduits is athermoplastic conduit, and the polymeric material is a thermoset,wherein the collar is configured to attach the thermoplastic conduitinto the thermoset body portion.
 6. The method of claim 2, wherein theat least one of the one or more fluid conduits is a thermoplasticconduit, and the polymeric material is a thermoplastic, wherein thecollar is configured to attach the thermoplastic conduit into thethermoplastic body portion.
 7. The method of claim 2, wherein the atleast one of the one or more fluid conduits is a thermoset conduit, andthe polymeric material is a thermoplastic, wherein the collar isconfigured to attach the thermoset conduit into the thermoplastic bodyportion.
 8. The method of claim 2, wherein the at least one of the oneor more fluid conduits is a thermoset conduit, and the polymericmaterial is a thermoset, wherein the collar is configured to attach thethermoset conduit into the thermoset body portion.
 9. The method ofclaim 2, further comprising providing an adhesive between the collar andthe fluid conduit.
 10. The method of claim 9, wherein the fluid conduitis a thermoset material.
 11. The method of claim 9, wherein the fluidconduit is a thermoplastic material.
 12. The method of claim 2, furthercomprising applying a primer to an exterior of the collar.
 13. Themethod of claim 1, wherein solidifying the polymeric material comprisescuring the polymeric material having an elongation to break of betweenabout 150% and about 1,500%.
 14. The method of claim 1, wherein the oneor more protrusions comprise a length less than or equal to a diameterof the mandrel.
 15. The method of claim 1, wherein the polymericmaterial is a thermoplastic.
 16. The method of claim 1, wherein thepolymeric material is a thermoset.
 17. The method of claim 1, whereinthe polymeric material is a silicone elastomer.
 18. The method of claim1, wherein the polymeric material is a perfluoropolyether elastomer. 19.The method of claim 1, comprising securing at least a portion of thefluid transfer assembly into a rigid housing.
 20. The method of claim19, wherein a material of the rigid housing is selected from the groupconsisting of polysulfone, polyether sulfone, polyester, polycarbonate,polyamide, polyetherimide, polyether ether ketone, polyolefins, ethylenetetrafluoro ethylene, cyanate ester, aluminum, stainless steel, carbonfiber epoxy, and glass filled plastics.
 21. The method of claim 1,comprising engaging one or more fluid control devices with at least oneof the conduits and the body portion to control fluid flow within thefluid transfer assembly.
 22. A method of forming a fluid transferassembly comprising: engaging one or more protrusions extendingoutwardly from a mandrel with one or more fluid conduits; positioningthe mandrel with the one or more protrusions engaging the conduits intoa mold; introducing a polymeric material into the mold to substantiallysurround the mandrel and at least a portion of the conduits engaged withthe one or more protrusions; solidifying the polymeric material in themold to define a fluid transfer assembly comprising a body portionengaged with the conduits; removing the fluid transfer assembly from themold; stretching the body portion into an elongated state via one ormore internal recesses defined by the body portion that enable the bodyportion to be stretched from an unelongated state into the elongatedstate; removing the mandrel with the one or more protrusions from thefluid transfer assembly by pulling the mandrel to remove the mandrelwith the one or more protrusions from the fluid transfer assembly withthe body portion in the elongated state; and relaxing the body portioninto the unelongated state from the elongated state such that a fluidchannel in fluid communication with the one or more conduits is formedwithin the body portion.
 23. The method of claim 22, comprisingpositioning sleeves in the mold prior to introducing the polymericmaterial into the mold, the sleeves defining the one or more internalrecesses in the body portion upon removing the fluid transfer assemblyfrom the mold.